[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsy-temporal-lobe\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsy-temporal-lobe":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,69,132,154,184,206,234,257,278,303],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":4,"leadSponsor":40,"locationsCount":43},"100153739","surgery-as-a-treatment-for-medically-intractable-epilepsy-100153739",false,"NCT01273129","Surgery as a Treatment for Medically Intractable Epilepsy","* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, candidates must:\n\n1\\. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded if they:\n\n1\\. Are unable or unwilling to give informed consent, or have a parent able to provide informed consent if a minor, to the research procedures.","ALL","8 Years","99 Years",{"count":19,"type":20},300,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment.\n\nObjectives:\n\n\\- To use surgery as a treatment for drug resistant epilepsy in children and adults.\n\nEligibility:\n\n\\- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.\n\nDesign:\n\n* Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.\n* Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.\n* Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.\n* Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).\n* Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.\n* Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.",[24,25,26],"Epilepsy","Epilepsy, Temporal Lobe","Partial Epilepsy",[28,29,24,30,31,32],"Neurosurgery","Childhood Epilepsy","Frontal Lobe Epilepsy","Temporal Lobe Epilepsy","Natural History","RECRUITING","2026-06-04",{"date":36,"type":37},"2026-06-05","ACTUAL",{"date":39,"type":37},"2011-03-21",{"name":41,"class":42},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100322511","investigating-epilepsy-screening-and-evaluation-100322511","NCT03478852","Investigating Epilepsy: Screening and Evaluation","* INCLUSION CRITERIA:\n* Age 8 years or older\n* Known or suspected diagnosis of epilepsy\n* Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent\u002Fguardian able to provide informed consent (for a child)\n* If unable to give informed consent, ability to give verbal assent\n\nEXCLUSION CRITERIA:\n\n* Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol\n* Patients who are unable to travel to the NIH","110 Years",{"count":52,"type":20},1000,"Background:\n\nEpilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.\n\nObjectives:\n\nTo learn more about seizures and find ways to best treat people with drug-resistant epilepsy.\n\nEligibility:\n\nAdults and children ages 8 years and older with diagnosed or suspected epilepsy\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nMedical history\n\nQuestionnaires\n\nParticipants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.\n\nParticipants will have many tests:\n\nBlood and urine tests\n\nEEG: Wires attached to the head with paste record brain waves. This may be videotaped.\n\nThinking and memory tests\n\nMRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.\n\nMEG: Participants lie on a table and place their head in a helmet to record brain waves.\n\nPET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.\n\nParticipants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.",[55,24,25,26],"Seizures",[57,55,58,59,60],"Seizure Disorder","Antiepileptic Drug","Natural History Study","Screening Protocol","2026-06-02",{"date":63,"type":37},"2026-06-03",{"date":65,"type":37},"2018-03-28",{"date":67,"type":20},"2027-07-30",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":15,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":96,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":131},"100640275","spatial-scene-recognition-memory-in-epilepsy-surgery-100640275","NCT07580183","Spatial Scene Recognition Memory in Epilepsy Surgery","Investigations of Spatial Recognition Memory to Improve Cognitive Outcomes in Epilepsy Surgery","Inclusion Criteria:\n\n* Age 18 years or older\n* For Aims I and III: Diagnosis of focal epilepsy or temporal lobe lesion; patients undergoing evaluation for or having undergone epilepsy surgery\n* For Aim II: Healthy adult participants\n* Full-Scale IQ ≥ 70\n* English proficiency sufficient to understand and complete the task\n* For Aim I: Enrolled in or eligible for Emory University epilepsy surgery research registry\n* For Aim III: Undergoing clinically indicated stereoelectroencephalography (SEEG) at UC Davis Medical Center\n* Able to provide informed consent (or for Aim I retrospective component, prior consent in Emory registry)\n\nExclusion Criteria:\n\n* Full-Scale IQ \\\u003C 70\n* Inability to provide informed consent\n* For Aim III: Age \\> 55 years\n* For Aim II: History of neurological or psychiatric disorder (as applicable per study protocol)",true,"18 Years","55 Years",{"count":80,"type":20},620,"INTERVENTIONAL",[83],"NA","This study investigates the anatomical and physiological basis of spatial scene recognition memory in patients with temporal lobe epilepsy and temporal lobe lesions. Standard neuropsychological tests are insensitive to important memory deficits experienced by patients, particularly in spatial\u002Fscene memory, recollective experience, and familiarity processing. Using a validated virtual tour paradigm, the study examines how familiarity-based recognition and recall of spatial scenes relate to specific brain structures. In Aim I, a large cohort of patients with varied temporal lobe lesions at Emory University undergoes the virtual tour task with voxel-based lesion-symptom mapping to localize necessary brain regions. In Aim II, scalp event-related potentials and eye tracking in healthy participants at UC Davis characterize the temporal dynamics and lateralization of scene recognition. In Aim III, intracranial EEG recordings (including local field potentials and single-unit activity) in epilepsy surgery patients at UC Davis determine the precise network dynamics underlying spatial scene familiarity and recall. The long-term goal is to improve the prediction and prevention of cognitive morbidity from epilepsy surgery by providing a more complete model of spatial recognition memory circuits.",[86,31,87,88,89,90,91,25,92,93,94,95],"Focal Epilepsy","Medically Refractory Epilepsy","Memory Disorders","Epilepsy Comorbidities","Epilepsy Intractable","Epilepsy Surgery","Memory Deficits","Memory Disorder, Spatial","Memory Dysfunction","Spatial Perception",[97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"spatial memory","recognition memory","familiarity","recollection","neural circuits of memory","phenomenology of memory","scene memory","virtual tour","epilepsy surgery","SEEG","stereo-electroencephalography","lesion-symptom mapping","network-symptom mapping","cognitive electrophysiology","event-related potentials","intracranial EEG","iEEG","parahippocampal gyrus","perirhinal cortex","hippocampus","tetrodes","deja vu","neuropsychology","consciousness","2026-05-06",{"date":123,"type":37},"2026-05-12",{"date":125,"type":37},"2024-07-01",{"date":127,"type":20},"2030-06-30",{"name":129,"class":130},"University of California, Davis","OTHER",2,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":76,"sex":15,"minAge":77,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":81,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100553205","phase-2-enhanced-mri-imaging-in-healthy-participants-and-participants-with-epilepsy-100553205","NCT06483061","Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy","Ferumoxytol Enhanced Hippocampal Vascular Imaging in Epilepsy","Inclusion Criteria:\n\n* Healthy controls aged 18-64.\n* Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan\n\nExclusion Criteria:\n\n* Non-English speaking participants will be excluded as we cannot provide translation services.\n* Inability to provide informed consent.\n* Contraindications to MRI Age \\\u003C 17 years \u002F \\>65 years\n* Weight \\> 127.5kg (which is the maximum weight of which a single 510mg vial of Ferumoxytol would accommodate a 4mg\u002Fkg dose).\n* Women of childbearing capacity with a positive pregnancy test\n* Women who are actively breast feeding\n* Contraindication of Ferumoxytol -known hypersensitivity to Feraheme or any of its components -History of allergic reaction to any intravenous iron product","64 Years",{"count":141,"type":20},50,[143],"PHASE2","Temporal lobe epilepsy (TLE) is a common type of epilepsy and one of the most likely to not be controlled by medication. For patients who do not respond to medication, surgery can result in a cure of seizures. Given the fact that around 50% of patients who undergo surgery are seizure free at 10 years there is a need to improve the understanding of what factors best predict surgical outcomes in order to improve our ability to select candidates for surgery.\n\nThe demonstration of abnormalities in the temporal lobe on MRI is one of the best predictors of seizure free surgical outcomes. Recent studies suggest that changes in specific subregions of the hippocampus could be the strongest predictors of surgical success, however the small size of these regions, (millimeters) make them very difficult to study with standard clinical MRI.\n\nRecently new MRI methods have been developed at Wayne State University to image hippocampal blood vessels using ferumoxytol infusion. Feraheme (ferumoxytol) is a drug that is approved in the United States for the treatment of iron deficiency anemia and is currently being studied as an MRI contrast agent in 8 active clinical trials in the United States as well as a Parkinson's Disease study in Canada.",[25],{"date":147,"type":37},"2026-05-08",{"date":149,"type":37},"2025-05-01",{"date":151,"type":20},"2029-09-01",{"name":153,"class":130},"University of Alberta",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":81,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100553948","a-pilot-study-to-evaluate-the-efficacy-and-safety-of-navifus-system-neuromodulating-treatment-for-patients-with-drug-resistant-epilepsy-100553948","NCT06492720","A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","Inclusion Criteria:\n\n1. Male or female patients aged over than and equal to 18 years old.\n2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.\n3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.\n\nExclusion Criteria:\n\n1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.\n2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).\n3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.\n4. Image documented calcified lesion in the FUS exposure path.\n5. Abnormal coagulation profile:\n\n   1. Platelet (PLT) \\\u003C 100,000\u002FμL.\n   2. prothrombin time (PT) \\> 15 sec.\n   3. activated partial thromboplastin time (APTT) \\> 45 sec.\n   4. international normalized ratio (INR) \\> 1.5.\n   5. Patients requiring anticoagulant medications.\n6. Pregnant or breast-feeding women.\n7. Coexisting medical problems of sufficient severity to limit compliance with the study.\n8. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.\n9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.\n10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study\n11. Any other condition that, in the investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.\n12. Any ASM treatment change during the baseline (screening period).\n13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).\n14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).\n15. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).\n16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.","65 Years",{"count":163,"type":20},16,[83],"This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).",[167,24,25,168],"Drug Resistant Epilepsy","Seizures, Focal",[170,171,172,173],"NaviFUS System","Focused Ultrasound","Low-Intensity Focused Ultrasound","LIFU","2026-04-06",{"date":176,"type":37},"2026-04-09",{"date":178,"type":37},"2024-09-01",{"date":180,"type":20},"2027-03-31",{"name":182,"class":183},"NaviFUS Corporation","INDUSTRY",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":76,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":81,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":43},"100412319","early-phase-1-localizing-epileptic-networks-using-mri-and-ieeg-100412319","NCT04649008","Localizing Epileptic Networks Using MRI and iEEG","Optimized Intracranial EEG Targeting in Focal Epilepsy Based Upon Neuroimaging Connectomics","Inclusion Criteria:\n\n* Patients with medication-refractory epilepsy\n* Planned intracranial EEG (IEEG) placement\n* Hypothesized to have temporal lobe epilepsy\n\nExclusion Criteria:\n\n* Contraindication to 3T MRI (e.g. metal implants or claustrophobia), clinical features that typically preclude the use of IEEG (e.g. pregnancy), prior intracranial surgery or device, and IEEG findings that are non-diagnostic (e.g. seizure onset zone(s) not identified)",{"count":192,"type":20},290,[194],"EARLY_PHASE1","Upon successful completion of this study, the investigators expect the study's contribution to be the development of noninvasive imaging biomarkers to predict IEEG functional dynamics and epilepsy surgical outcomes. Findings from the present study may inform current and new therapies to map and alter seizure spread, and pave the way for less invasive, better- targeted, patient-specific interventions with improved surgical outcomes. This research is relevant to public health because over 20 million people worldwide suffer from focal drug-resistant epilepsy and are potential candidates for cure with epilepsy surgical interventions.",[24,90,25],"2026-02-11",{"date":199,"type":37},"2026-02-13",{"date":201,"type":37},"2021-03-01",{"date":203,"type":20},"2027-02-28",{"name":205,"class":130},"University of Pennsylvania",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":81,"phases":216,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100548586","phase-1-a-phase-12-study-of-nrtx-1001-neuronal-cell-therapy-in-drug-resistant-bilateral-mesial-temporal-lobe-epilepsy-mtle-100548586","NCT06422923","A Phase 1\u002F2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE)","A Phase 1\u002F2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Temporal Lobe Epilepsy (MTLE)","Key Inclusion Criteria:\n\n1. Male or female, age 18-75 years.\n2. Subjects of childbearing potential will use highly effective contraception.\n3. Proven history of focal seizures of hippocampal origin with bilateral seizure foci confirmed by scalp or intracranial ictal EEG (including confirmation by recordings from responsive neurostimulation \\[RNS\\] electrodes when applicable).\n4. Either\n\n   1. bilateral hippocampal sclerosis on MRI (evidenced by increased FLAIR signal intensity in both hippocampi or by visual assessment showing reduced volume compared to normal) or\n   2. bilateral temporal hypometabolism on 18-Flourodeoxyglucose Positron Emission Tomography (FDG PET) (assessed by visual assessment, comparing temporal regions to frontal\u002Fparietal lobe neocortex). In this case, ictal EEG recordings must also include intracranial confirmation.\n\n      or\n   3. a combination of unilateral instances of the evidence described in a. and b. (e.g., one side can be evidenced by criterion a. and the other side by criterion b.) MRI or PET scans used for assessment must have been acquired within 3 years of screening.\n5. Subject has had at least four clinical focal seizures, including at least two clinical focal seizures with objective manifestations, on average, per month for the 6 months prior to screening.\n6. Subject has previously had adequate (in opinion of investigator) therapeutic trials of at least two Anti-Seizure Medicines (ASMs).\n7. Current ASM regimen, and doses of other drugs known to affect seizure frequency (e.g., antidepressants), have been stable for at least three months prior to enrollment.\n8. Subject can converse and read in English or Spanish. Able to participate in required study procedures and provide signed informed consent.\n\nKey Exclusion Criteria:\n\n1. Epilepsy due to other and\u002For progressive neurologic disease.\n2. Evidence of seizure focus outside hippocampus (either by seizure semiology or EEG findings).\n3. MRI indicating potential malignant lesion (low-grade glioma of any type is excluded) in any location or non-malignant potentially epileptogenic lesion outside the hippocampus. Small (\\\u003C2 cm) non invasive meningioma, remote from the affected temporal lobe, is not exclusionary.\n4. Seizures of non-focal origin.\n5. History of status epilepticus in the year prior to screening, as guided by ILAE criteria (Trinka 2015) in the judgement of the PI. A history of cluster seizures is permitted.\n6. Psychogenic Non-Epileptic Seizures (PNES) within the past 3 years.\n7. Severe psychiatric disorders.\n8. Primary or secondary immunodeficiency.\n9. Pregnancy, or currently breastfeeding.\n10. Suicide attempts in past year.\n11. Significant other medical conditions which would impair safe participation.","75 Years",{"count":215,"type":20},10,[217,143],"PHASE1","This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory nerve cells called interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.",[25],[221,222,223],"Bilateral Temporal Lobe Epilepsy","Bilateral MTLE","Refractory Bilateral MTLE","2026-01-05",{"date":226,"type":37},"2026-01-07",{"date":228,"type":37},"2024-11-14",{"date":230,"type":20},"2042-06-15",{"name":232,"class":183},"Neurona Therapeutics",17,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":81,"phases":243,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":43},"100512069","evaluation-of-the-navifus-system-in-drug-resistant-epilepsy-100512069","NCT05947656","Evaluation of the NaviFUS System in Drug Resistant Epilepsy","An Open-label, Non-randomized, Single-arm Pilot Study to Evaluate the Safety and Efficacy of Multiple Pulsed Focused Ultrasound Treatment in Patients With Drug Resistant Temporal Lobe Epilepsy","Inclusion Criteria:\n\n1. Diagnosis of drug resistant temporal lobe epilepsy (TLE)\n2. Patients must experience at least four (4) observable seizures over the 60-day baseline, each on a separate day.\n3. Patients have focal-onset seizures with or without secondary generalization.\n4. Patients have had at least 24 hours video-electroencephalography (EEG) monitoring and comprehensive epilepsy evaluation confirming TLE.\n5. Seizure medication treatment is anticipated to remain stable during the trial, except for rescue medicines or occasional extra doses of ongoing medicines, as required.\n6. Patients should be capable of and willing to completing assessments and neuropsychological testing in English either alone or with the help of the study partner (where appropriate), per local guidelines. A study partner is a carer or family member of the patient.\n7. Patients and study partner (if applicable) who in the Investigator's opinion are reliable and able to use the seizure diary to record seizure throughout the study and are willing to comply with study procedures and visits.\n\nExclusion Criteria:\n\n1. Patients who have primary generalized epilepsy or non-epileptic seizures in the last two (2) years.\n2. More than two (2) seizure onset zones (foci) (except bitemporal foci) or unknown likely site of seizure onset, as determined by usual clinical, electroencephalography (EEG) and imaging practice.\n3. Patients who have experienced tonic-clonic status epilepticus in the three (3) months leading up to enrollment in the study.\n4. Presence of devices including but not limited to cardiac pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, responsive neurostimulator (RNS) or deep brain stimulation (DBS). Vagus nerve stimulators (VNS) do not represent an exclusion criterion, but settings should be stable throughout the trial.\n5. Patients with clips or other metallic implanted objects in the FUS exposure path, except shunts.\n6. Patients with more than thirty percent (30%) of the skull area traversed by the sonication pathway covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp at Screening.\n7. Patients who have a medical or surgical history of severe systemic disease(s), such as (but not limited to) coronary artery disease, myocardial infarct, progressive heart failure, uncontrolled hypertension or abnormal ECG, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg), chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome, hepatic and renal insufficiency (ALT or AST 3 times above normal range; serum creatinine \\> 1.3 mg\u002FdL), diabetic patients with poor control of blood sugar (HbA1c \\> 8.5 %) at Screening.\n8. History of intracranial hemorrhage.\n9. History of multiple strokes, or a stroke within the six (6) months prior to Screening.\n10. Patients with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment at any time.\n11. Presence of central nervous system (CNS) disease(s) other than epilepsy including but not limited to infections of the CNS (e.g., syphilis, Lyme disease, borreliosis, viral or bacterial meningitis\u002Fencephalitis, human immunodeficiency virus \\[HIV\\] encephalopathy), cerebral vascular disease, Parkinson's disease, traumatic brain injury, alcoholic encephalopathy within three (3) years prior to Screening.\n12. Patients with concurrent major psychiatric disorder, such as schizophrenia or bipolar disorder, severe depression, active suicidal ideation, active psychosis (excluding time-limited postictal psychosis) or psychiatric hospitalization within one (1) year before Screening.\n13. Prior diagnosis of cancer within the past two (2) years and evidence of continued malignancy within the past two (2) years (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).\n14. Patients who are not able or willing to tolerate the required prolonged stationary semi-supine position during treatment.\n15. Inability to tolerate MRI procedures or contraindication to MRI (e.g. claustrophobia, too large for MRI scanner), including, but not limited to, presence of pacemakers (with the exception of MRI-safe pacemakers), aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or other areas of the body that would contraindicate an MRI scan.\n16. Patients who had major surgery six (6) weeks before study enrollment or who are not fully recovered from a surgical procedure or with planned surgery during study period or within fourteen (14) days thereafter.\n17. Patients who have received radiofrequency thermocoagulation (RFTC) within two (2) months of Screening.",{"count":242,"type":20},18,[83],"Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi.\n\nThe study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.",[25,167],[171,247,31],"Drug Resistant Temporal Lobe Epilepsy","2025-07-01",{"date":250,"type":37},"2025-07-03",{"date":252,"type":37},"2023-10-02",{"date":254,"type":20},"2026-07-01",{"name":256,"class":183},"Genovate-NaviFUS (Australia) Pty Ltd.",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":76,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":81,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":43},"100465339","pre-operative-mapping-of-the-anterior-temporal-lobe-using-functional-mri-innovative-techniques-in-in-drug-resistant-epileptic-patients-100465339","NCT05339438","Pre-operative Mapping of the Anterior Temporal Lobe Using Functional MRI Innovative Techniques in in Drug-resistant Epileptic Patients","CARTA","Inclusion Criteria:\n\n* Adult person,\n* Person affiliated to a social security scheme or beneficiary of such a scheme,\n* Person having received complete information on the organization of the Clinical Investigation and having signed informed consent,\n* Person having carried out a preliminary clinical examination adapted to the Clinical Investigation,\n* For patients: Person with drug-resistant structural focal epilepsy of the anterior temporal lobe (right or left), candidate for epilepsy surgery (anterior temporal lobectomy),\n* For healthy volunteers: Person with no known pathology in the anterior temporal lobe (particularly epilepsy).\n\nExclusion Criteria:\n\n* Contraindication to MRI including claustrophobia,\n* Uncorrected visual disturbances,\n* Person unable to give consent,\n* Lack of mastery of the French language or ability to understand instructions,\n* Person referred to in Articles 64, 65 and 66 of European Regulation 2017\u002F745: Person of full age unable to consent alone to participate in the Clinical Investigation; Minor; Pregnant or breastfeeding woman.",{"count":265,"type":20},30,[83],"Anterior temporal epilepsy is the most frequent form of focal epilepsy (more than 50% of focal epilepsies). The epilepsy is drug-resistant when epileptic seizures persist despite antiepileptic treatment (25% of cases). In this case, it is possible to offer a surgical solution to the patient: an anterior temporal lobectomy. This surgery consists of removing the entire portion of the temporal lobe responsible for epilepsy (epileptogenic zone), that is to say a major part of the temporal pole, the hippocampus and the ventral anterior temporal lobe (vATL). The goal of the surgery is to lead to a disappearance of the seizures while preserving the functions of the patient. This is why a pre-surgical assessment is systematically carried out in order to locate the epileptic focus and to predict the risks of neurological and cognitive deficits. The vATL is of particular interest because it is a highly functional region, involved in naming, semantic processing and face recognition. A resection of this region by anterior lobectomy can therefore impact these functions and lead to cognitive deficits (for example, up to 65% decline in naming), which can be disabling in the lives of patients, even if they are free from seizures. One of the major challenges of epilepsy surgery is therefore to predict the postoperative neuropsychological outcome. The prediction of the neuropsychological outcome of the post-surgery patient is largely based on the mapping of functional regions preoperatively, carried out by functional MRI (fMRI), or by electrical stimulation carried out during intracerebral exploration by StereoElectroEncephalography (SEEG).\n\nHowever, current techniques have drawbacks. Electrical stimulations are based on an invasive exploration (SEEG), are time-consuming and sometimes difficult to interpret. The fMRI sequences used in clinical routine do not make it possible to visualize the entire vATL region because of artifacts related to the auditory canal. Thus, the signal is strongly diminished in this region, rendering a large area of the vATL invisible. This results in insufficient visualization of activated vATL regions when performing tasks such as naming, semantic processing, and face recognition. Important functional regions can therefore be removed during surgery and negatively impact the patient's neuropsychological outcome.\n\nIn the CARTA study, original methods are associated in order to increase the signal-to-noise ratio in vATL. On the one hand, the Multi-Band sequence, an innovative fMRI sequence, will be used. On the other hand, a particular method of presentation of visual stimuli will be used, called fast periodic visual stimulation (FPVS: Fast Periodic Visual Stimulation), during which the stimuli are presented periodically (fixed frequency). Individually, these methods improve vATL (signal enhancement) exploration. The investigators assume that the combination of the two methods may have a potentiating effect, compared to the standard SMS (Simultaneous Multi-Slice) sequence. fMRI exploration will not influence the surgical management of the patient included in the study because it is the beginning of the development of this technique, but could be used, in the longer term, to guide the surgeries of epileptic patients.\n\nThus, the goal of this study is to precisely map the vATL, using innovative methods in fMRI. This mapping will make it possible to study the cerebral functions of the vATL involved in naming, semantic processing and face recognition, and ultimately improve the postoperative neuropsychological prognosis of epileptic patients.",[25,269],"Cognitive Decline","2025-06-26",{"date":248,"type":37},{"date":273,"type":37},"2022-06-10",{"date":275,"type":20},"2027-06-09",{"name":277,"class":130},"Central Hospital, Nancy, France",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":81,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":131},"100417569","pathophysiology-psycho-emotional-and-cognitive-functioning-associated-with-tinnitus-100417569","NCT04717388","Pathophysiology, Psycho-emotional and Cognitive Functioning Associated With Tinnitus","Cognitive and Emotional Function and Brain Reorganisation Associated to Auditory Abilities : Impact of Tinnitus","AudiCog","Common Criteria for Inclusion :\n\n* Age ≥ 18 years old\n* Good written and oral comprehension of the French language\n* Person affiliated to a Social Security scheme\n* Informed consent signed by the participant\n* Normal or corrected vision\n* Absence of known pre-existing neurological and\u002For degenerative disorders\n\nGroup Specific Inclusion Criteria :\n\nTinnitus+ Group - Suffering from subjective uni- or bilateral tinnitus, chronic (\\>3 months) and stable (no period of remission).\n\nChir+ Group\n\n\\- Surgically treated for drug-resistant epilepsy of the temporal lobe (including the amygdala).\n\nGroup Tinnitus-\n\n* Not suffering from tinnitus Group Chir-\n* Non epileptic\n* Not having undergone surgical treatment of the temporal lobe (including the tonsil)\n\nExclusion criteria:\n\n* Presence of severe or profound deafness, uni or bilateral.\n* Under legal protection (guardianship, curators, etc.)\n\nAdditional criteria for patients completing visit V2 :\n\n* MRI contraindicated or claustrophobic\n* Pregnant or breastfeeding woman.",{"count":19,"type":20},[83],"the investigators have recently shown that patients with drug-resistant temporal lobe epilepsy who have undergone brain surgery targeting the medial temporal lobe structures were more likely to develop tinnitus postoperatively. This discovery of a vulnerability to tinnitus associated with medial temporal lobe surgery to eliminate drug-refractory epileptic seizures provides a new clinical model of tinnitus, targeting temporal lobe regions as generators or mediators of this hearing disorder. The objective of this project is to study the impact of tinnitus on the cognitive, emotional, psychoacoustic and cerebral functioning associated with this hearing disorder, and to clarify the pathophysiology of tinnitus by comparing different groups of individuals with tinnitus (surgical epileptic patients or non-surgical ORL patients) to matched tinnitus-free groups (surgical tinnitus-free cases and healthy controls volunteer).",[290,25],"Tinnitus",[290,24,292,293],"Cognitive Functioning","Brain connectivity","2024-12-11",{"date":296,"type":37},"2024-12-12",{"date":298,"type":37},"2021-06-15",{"date":300,"type":20},"2029-04-15",{"name":302,"class":130},"Assistance Publique - Hôpitaux de Paris",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":76,"sex":15,"minAge":77,"maxAge":161,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":320,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100520489","innovative-mri-to-localize-the-epileptic-zone-100520489","NCT06057233","Innovative MRI to Localize the Epileptic Zone","Quantitative MRI and GABA Spectroscopy to Localize the Epileptic Zone","EPI-CATCHER","Inclusion Criteria:\n\n* Patient group\n\n  * Patients aged 18-65 years,\n  * Patients with drug-resistant focal epilepsy,\n  * Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,\n  * Negative pregnancy test for child-bearing aged woman,\n  * Obtained signed informed consent from patient\n* Reference group\n\n  * Male or female, 18-65 years,\n  * Obtained signed informed consent from participants,\n  * Negative pregnancy test for child-bearing aged woman\n\nExclusion Criteria:\n\n* Patient group\n\n  * Patient without social security system\n  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations.\n  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),\n  * Contraindication for MRI,\n  * Contraindication for injection of MRI contrast agent (Gd-Chelate),\n  * Evidence on neuroimaging (CT or MRI) of a brain lesion in the same hemisphere as the EZ (tumor, stroke, cerebral edema with midline shift and a clinically significant compression of ventricles, or subarachnoid hemorrhage, or intracerebral parenchymal hematoma (petechial small hemorrhages are NOT a non-inclusion criteria),\n  * Severe leucoariosis\n  * Pre-existing dementia\n  * Pregnant, breastfeeding women\n* Reference group\n\n  * Person who is participating in another therapeutic trial\n  * Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts\n  * Person without social security system,\n  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations,\n  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),\n  * Contraindication for MRI\n  * Contraindication for injection of MRI contrast agent (Gd-Chelate)\n  * Pregnant, breastfeeding woman.",{"count":312,"type":20},40,"The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ.",[25],[316,317,318,319],"MRI","Quantitative","GABA","MRS","NOT_YET_RECRUITING","2024-08-22",{"date":323,"type":37},"2024-08-23",{"date":325,"type":20},"2024-10",{"date":327,"type":20},"2028-11",{"name":329,"class":130},"University Hospital, Grenoble"]